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质量报告单
CERTIFICATE OF ANALYSIS
品 名 Product Name |
盐酸金霉素 Chlortetracycline HCl |
数 量 Quantity |
200kg |
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批 号 Batch No |
20240409 |
包 装 Packing |
25kg/drum |
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生产日期 MFG. Date |
2024.04.22 |
有 效 期 Exp. Date |
2026.04.23 |
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检验依据 Pef. standard |
英国药典2000 |
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检验项目 Test Items |
检验指标 Specification |
检验结果 Test Results |
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性状Character |
黄色粉末Yellow powder |
通过Approved |
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鉴别Identification |
满足要求Meets the requirements |
通过Approved |
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比旋度Spec rotation |
-235o~-250o |
-242o |
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酸度PH value |
2.3~3.3 |
2.6 |
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吸光度(E05%1cm) |
≤0.40(460nm) |
0.277 |
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干燥失重Loss on drying |
≤2.0% |
0.73% |
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硫酸灰分Sulphated Ash |
≤0.5% |
0.1% |
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重金属Heavy metals |
≤50ppm |
通过Approved |
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有关杂质Related Substances |
满足要求 Meets the requirements |
通过Approved |
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盐酸金霉素CTC.HCl |
≥89.5%(HPLC) |
89.70% |
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盐酸四环素TC.HCl |
≤8.0%(HPLC) |
5.53% |
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盐酸差向金霉素 4Epl-CTC.HCl |
≤4.0%(HPLC) |
2.25% |
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盐酸四环素加盐酸金霉素TC.HCl+CTC.HCl |
94.5~102%(HPLC) |
95.23% |
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检验结论Conclusion |
合格 Qualified |